Acrivon Therapeutics, Inc. (ACRV), Wednesday, announced that the FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the treatment of endometrial cancer.
The ACR-368-tailored OncoSignature assay is being used to identify patients most likely to respond to the company's lead drug candidate ACR-368 in an ongoing, registrational-intent, phase IIb trial in patients with endometrial cancer and other tumor types.
The Breakthrough Device designation indicates that the multiplex immunofluorescence assay is reasonably expected to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
In the registrational intent, phase II trial of ACR-368 in patients with locally advanced or metastatic, recurrent endometrial cancer, the results of which were reported last year, a confirmed overall response rate of 62.5% was observed in prospectively-selected ACR-368 OncoSignature-positive (BM+) patients with endometrial cancer.
Currently, Acrivon's stock is trading at $6.29, up 6.43 percent on the Nasdaq.
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